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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01560000
Other study ID # 1202E10321
Secondary ID
Status Completed
Phase N/A
First received March 5, 2012
Last updated March 13, 2013
Start date March 2012
Est. completion date December 2012

Study information

Verified date March 2013
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The objective of this study is to determine the satiety value of different bran fibers on appetite & subsequent food intake with acute consumption. Satiety will be measured subjectively by visual analogue scales (VAS).


Description:

Visual analogue scales will be used to measure satiety at 15, 30 45, 60, 120, 180, and 240 minutes


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility Inclusion Criteria:

- healthy women between the ages of 18-40

- body mass index between 18.5-29.9kg/m2

- eat breakfast regularly

- nonsmoking

- not taking weight loss medications

- non-dieting (weight stable over the past 3 months)

- spoken and written English literacy.

Exclusion Criteria:

- antibiotic use within the past 6 months

- cardiovascular disease

- diabetes mellitus

- cancer in the past 5 years

- renal or hepatic disease

- recent bacterial infection

- gastrointestinal conditions affecting digestion or absorption

- weight loss>5kg in prior 3 months (intentional or unintentional)

- history of drug or alcohol abuse in prior 6 months

- food allergies

- high fiber intake(3 or more servings of high fiber foods per day)

- lipid-lowering, anti-hypertensive or anti-inflammatory steroid medication use

- restrained eater(score>10 on the dietary restraint factor of the Three Factor Eating Questionnaire)

- concurrent or recent (within 30 days) participation in an intervention study.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Dietary fiber
Wheat, barley, oat and bran fibers added to a breakfast product

Locations

Country Name City State
United States University of Minnesota Saint Paul Minnesota

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Satiety response 4 hours No
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